Two weeks after a massive recall of several brands of pet foods and after dozens of dogs and cats have died of unexplained intestinal ills, scientists at FDA's Forensic Chemistry Center in Cincinnati make an unusual discovery: There are high levels of melamine in the food.
An industrial chemical used to make plastics and sterilize swimming pools, the melamine seems to have come from the added wheat gluten. But how did it ever get in that ingredient?
In another two weeks, the whole country would learn how China had become one of the world's leading suppliers of ingredients, and not just for pet foods. That's right, the same country known for cheap angora wool sweaters, lead-based paint on toys and knock-offs of copyrighted and trademarked goods was supplying us with basic ingredients for our foods. And consumers didn't even know it.
Consumer reactions were numerous and varied. How could this happen in America, where consumers enjoy one of the safest food supplies in the world? This time it involved pets, but could the same thing happen to human food? And when did we start importing food ingredients from China?
Perhaps that last question was the most perplexing. American parents, who also had begun returning toys and children’s jewelry tainted with lead paint, were learning what a huge trading partner China had become. Now did they have to worry if there are dangerous Chinese ingredients in their frozen pizza?
A $2 trillion issue
The same economic factors making China the source of millions of Mattel toys – and Vietnam the world’s leading exporter of pepper – are making developing nations the source of many of our (and the world’s) food ingredients.
Some 80 percent of the world’s ascorbic acid – vitamin C, used as a preservative -- is now made in China. So is 40 percent of the world’s xanthan gum. China is the leading provider of seafood to the U.S.
The burgeoning global economy results in the importation of foods and ingredients by 825,000 importers from 150 countries, some from developing countries without strong food-safety inspection systems.
There are economic factors pushing growth in food imports, explains David Acheson, who just got a new FDA title in January: associate commissioner for foods. "(For consumers), the expectation is, ‘I don't want to pay $5 for a head of lettuce.’ How are you going to deal with that? You import the food.”
Imports of food and ingredients alone amount to 25,000 shipments every day, according to the commissioner. “Food imports grew at an average annual rate of 14 percent per year, and during the past five years, FDA-regulated food imports from China increased by more than 140 percent,” he says.
Food labels must indicate the list of ingredients and where the end-product is made, but there’s no requirement to list the country of origin of the ingredients. A product made in the U.S. might contain ingredients from China, Mexico, India or South Africa. Anywhere along the way, some unscrupulous supplier or the ingredient importer might substitute a food-grade product with a cheaper or industrial-grade version. Or worse.
Imports of all sorts in 2007 totaled more than $2 trillion, or twice of the economy of Brazil, according to Michael Leavitt, secretary of Health and Human Services (parent of the FDA). “And we're likely to see it grow even further because as the world continues to flatten and as the global economy continues to expand, we expect we'll see as much as three times the amount of import activity in this country by 2015 as we do now,” he told National Public Radio.
Arriving through 300 ports of entry, shipments of food into the U.S. have quadrupled since 1996, when our agricultural trade balance was more than $27 billion. Today, U.S. agricultural and food exports outweighed imports by a scant $8 billion. Individual shipments of food and ingredients from China alone have grown from 82,000 in 2002 to 199,000 in 2006 and are expected to soon hit 300,000.
Simply too complex
The $64,000 question becomes: How can the U.S. government and the food industry make certain imported foods and ingredients are safe for consumers and how do they protect their brands?
First, let’s take the government.
A complex regulatory environment exists in the U.S. More than a dozen federal agencies oversee various aspects of food safety. Primarily, FDA shares responsibility with USDA, Dept. of Homeland Security, Centers for Disease Control and Prevention and state health and agricultural agencies. And you wonder why the government outsources organic certification.
Today, regulatory authorities not only have to look at the quality of imports but they must be watchful for harmful chemicals and contaminants introduced by terrorists.
Oversight for $417 billion worth of domestic food and some $60 billion of imported food each year is the purview of the FDA. That includes about 80 percent of the food supply -- just about everything we eat except for meat, poultry, dairy and some egg products, which are regulated by USDA.
Unlike the USDA, the FDA has no authority to require a foreign country to send us safe food. Its job is to find unsafe food at the port of entry. Given the high number of imports, FDA can only physically inspect a small percentage of products, so a risk-based approach is the most sensible way to identify products for inspection.
FDA claims to “screen” 100 percent of the foods that legally enter the U.S. and are subject to its authority, according to an FDA spokesman. Inspectors then target and identify the products and countries of origin for which it has the greatest concern. Those products, representing 1 to 2 percent of the food imports regulated by FDA, are physically inspected, and FDA samples a subset of these for lab analysis.
Under the current food import system, any country or company can export food products to the U.S. if they notify regulators of the shipment. The FDA does not ensure trading partners have equivalent standards, nor can the agency inspect overseas plants when problems arise. So when there is an outbreak, the FDA’s investigation can be delayed by uncooperative foreign governments.
During the pet food recall, U.S. regulators were delayed three weeks in their request for visas to inspect Chinese facilities. Since then, FDA has restricted imports of some pet-food ingredients and some seafood from China.
Processors, suppliers responsible
As the law is written, it’s really the responsibility of the food processor to provide safe and properly labeled food and to make sure imported products are safe. Many companies protect their customers, brand name and stockholders by taking extra safety measures to ensure their suppliers’ products are safe.
“Nestlé is a global company that operates in almost every country of the world, including China,” says Edie Burge, spokesperson for corporate and brand affairs at Nestlé USA, Glendale, Calif. “We have long-term relationships in China with a large number of suppliers and have established high quality standards for the ingredients they supply.
“Being part of an international company with geographically diverse operations gives us the advantage of having on-the-ground resources to stay informed on quality assurance issues, and that assists in our continuous improvement efforts. Nestlé has rigorous processes in place to monitor materials that we import from around the world. Product quality is our No. 1 priority.”
Battle Creek, Mich.-based Kellogg Co. also has safeguards in place. “All of our suppliers must meet stringent Kellogg requirements, which include third-party audits, food safety and compliance to all applicable regulations − regardless of the country of origin,” says spokesperson Kris Charles. “We constantly review our food safety programs and have arranged additional third-party audits of our suppliers in China as an extra precautionary measure.”
Tyson Foods Inc., Springdale, Ark., manufactures products in China – both for domestic and export consumption. “We use only suppliers that are already certified for Japanese export [which is a higher standard than domestic China production], ensuring we start with the best suppliers,” explains James Rice, Tyson’s vice president and general manager–Greater China. “These suppliers, and their suppliers, are audited regularly by our American quality assurance manager, and we practice 100 percent inspection on all raw materials coming into our facility.
“When Tyson products are manufactured by our partners, our quality assurance manager and our American production manager are in those facilities ensuring the same quality standards are maintained. Our global customers also audit our plants and our suppliers. The net result is regulators, the manufacturer, and customers are working together to ensure the quality of our products.”
He adds, “As the brand owner, our job is to be certain all levels of private and public sector quality assurance work together to identify, manage and mitigate all food safety risks.”
Rice, who has 18 years experience working in China, believes the country’s modern manufacturers and its governmental food quality watchdog, the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), have the processes and the commitment to ensure quality food products are made for export.
However, “Any food company importing food or food ingredients today is just as vulnerable as those in the pet food industry in 2007 unless they have an extensive import program in place addressing food safety,” warns Gale Prince, a pioneer food safety expert with 40 years of experience with major U.S. food companies.
“Too often the decision between purchasing domestic and imported ingredients is based upon cost of the basic ingredients,” he continues. “Responsible firms need to know who is producing their imported products and ingredients and where. This includes a facility inspection of the foreign producing firm and evaluation of operational practices and technical expertise.”
“Gadot Biochemical Industries Ltd. is currently building a plant for citric acid and sodium citrate in China, and we will apply the same quality levels and quality systems as we have in our plant in Haifa, Israel,” says Ronny Hacham, vice president business development and marketing. "Products will meet USP/BP/JP/NF/FCC monographs, and the plant will grant GMP, HACCP, ISO 9000 and ISO 14000 certificates -- certified by Western certification bodies.
“Pharmline, our American company, sources many ingredients in China and India, and applies very stringent QC procedures,” adds Hacham. “As has been the case for years, it can provide traceability of every incoming raw material to the pallet or drum level.”
Pharmline is about to announce the reopening of an office in China, and this new operation will be focused on quality assurance and vendor compliance issues. The company plans to conduct regular GMP audits of its top vendors, environmental audits and regular web meetings with vendor quality control departments to collaborate on analytical methodologies, HACCP and current issues of concern to industry. “This will add another level of confidence in the quality of ingredients Pharmline currently sources in China,” says Hacham.
“It is still critical for the food processor to visit the ingredient supplier -- wherever they are located -- and build a close relationship of understanding and trust,” says Bob Hoopingarner, vice president of sales and marketing at International Dehydrated Foods Inc. (www.idf.com), Springfield, Mo.
“If the supplier can prove they operate under the proper guidelines, if they use the [appropriate] processes to insure product and employee safety, including facility security, and if they can prove they will meet the customers’ needs with every shipment, they deserve to be considered a reliable, safe source of supply. But there’s a cost associated with doing that,” he notes.
“When dealing with imported foods or ingredients you must think outside of the traditional quality control box and include in your considerations the production practices, ecological and social conditions in the exporting country,” says Prince. “History has shown the need to give additional attention to chemical contaminants, but attention must also be given to authenticity testing of imported products and certificates of analyses.
“You must constantly review international food safety intelligence and apply the elements learned in the design of your food safety program to make sure your products meet consumer expectations.”
Because the cost of product recalls in the past year has affected corporate earnings, “Food safety not only should be on the agenda of the food firm’s top executives but also on the oversight agenda of their board of directors,” adds Prince. “Unfortunately, most corporate food company board membership is made up of expertise in financial and legal [segments] and has not included representation with expertise in food safety. But food safety is a key component to a food firm’s core business.”
Our Achilles’ heel
“Imports are our Achilles’ heel,” says Ken Lee, professor and director of Ohio State Food Safety Center, Ohio State University. “There is no global food regulator. If the Chinese want to put an adulterant into food, they can do it until they get caught. I’ll wager it will happen again, because it’s driven by the profit motive.”
The real dilemma is no technology can totally ensure safe imports. Irradiating every container entering the U.S. has been suggested, but the cost is prohibitive, would delay delivery and consumers are still wary about the technology. And while irradiation kills pathogens, it won’t solve the problem of adulterated ingredients or poisons.
Inspections of all containers would require vast increases in the FDA and USDA budgets. Meanwhile, FDA is inspecting products from China and other countries with less stringent internal food safety controls than ours, and relaxing inspections from countries such as Britain and Canada, which have stronger standards. And, FDA might require importers and U.S. processors using imported ingredients to provide far more detailed information about the production processes in place at foreign suppliers.
For years, some members of Congress have called for a streamlining of the system. The large number of recalls last year (or better reporting methods) and melamine contamination has spurred delegates to action.
Pressure is on from both industry and consumers. According to a recent Consumer Reports study, 92 percent of Americans want to know which country produced the food they buy. And a 2007 survey by The Food Marketing Institute found consumer confidence in food safety has plummeted to 66 percent, down from 82 percent the year before.
In July 2007, President Bush issued an executive order creating a cabinet-level Interagency Working Group on Import Safety to conduct a review of the U.S. import system, regulations, procedures and practices and identify ways to increase the safety of imports. Chaired by HHS Sec. Mike Leavitt and comprised of 12 federal departments and agencies, working group members visited more than two dozen cities across the country, covering ports, railroads, airports, freight hubs, border crossings, wholesalers, retailers, fruit stands and meat and seafood processing facilities. Its initial findings contained 14 broad recommendations and 50 action steps -- a road map for enhancing the safety of the increasing volume of imports entering the U.S.
Last Nov. 6, Secretary Leavitt presented the Import Safety Action Plan with recommendations and specific short- and long-term steps, categorized under the principles of prevention, intervention and response. The report concluded the U.S. must transition from an outdated “snapshot” approach to import safety, in which decisions are made at the border, to a prevention-focused model that targets critical points in the import life cycle where the risk of the product is greatest, and then verifies the safety of products at those important phases.
Simultaneously, FDA developed a comprehensive Food Protection Plan, unveiled in November 2007, to address the changes in food sources, production and consumption. The new plan presents a strategy to protect the food supply from both unintentional contamination and deliberate attack. It builds in prevention first, then intervention, and finally response.
But is there money to do all this?
A subcommittee of the FDA’s Science Board released a report detailing how underfunding of the agency is jeopardizing FDA’s ability to protect the food supply (see www.fda.gov/ohrms/dockets/ac/oc07.htm).
Funding for the FDA should be doubled over the next two years and manpower increased by 50 percent, says Peter Barton Hutt, former chief counsel of the FDA, internationally recognized partner in Washington law firm Covington & Burling and adjunct food and drug law professor at Harvard Law School. Hutt also implores the food industry to lobby Congress to increase funding.
The FDA’s FY 2007 budget was $453 million for food alone (for the Center for Food Safety and Applied Nutrition and for related field activities in the Office of Regulatory Affairs), according to the Appropriations Bill. FDA food programs cover food safety, food defense, dietary supplements, nutrition and cosmetics. In the current fiscal year, ending Sept. 30, appropriations were increased to $513.5 million.
Is a 13 percent increase enough?
No, said a coalition of voices in a press conference in the U.S. Capitol in December. Sens. Dick Durbin and Edward Kennedy, Grocery Manufacturers Assn., Food Marketing Institute, American Frozen Food Institute, the Coalition for a Stronger FDA/FDA Alliance, the Center for Science in the Public Interest and the Consumer Federation of America all called on the White House to increase FDA’s food safety resources.
“For years, Congress has pointed out the FDA is understaffed and underfunded,” says Durbin. “I am calling on the administration to commit to doubling FDA funding over the next five years. We simply cannot leave American families vulnerable when it comes to food safety.”
In response to the melamine contamination, a number of new food safety measures were introduced by China. A four-month crackdown resulted in the closing of 3,191 unlicensed and substandard food makers, the seizure of 4.9 million tons of banned pesticides and a pledge to spend $1 billion on food safety by 2010. Oh, and the execution of the head of China’s food and drug agency, who was convicted of taking bribes.
Hailed as the biggest breakthrough, Chinese officials agreed to implement a tracking and data-sharing program for a limited number of foods, drugs and medical devices bound for the U.S. Under the agreements, the U.S. will be able to track certain food and drug exports from China as part of a broader registration and certification process designed to allay worries about the quality of Chinese products.
Wang Daning, China’s chief inspector of exported food, says his agency, the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) with a staff of 7,000, is working hard to strengthen oversight. He suggests China’s food exports have been unfairly tarnished.
“Only about 12,700 companies in China are approved by AQSIQ to export food products, just a fraction of the roughly 450,000 food processing companies in the country,” he said. “I have seen the records for 3½ years of Chinese exports. The quality is very stable, as more than 99 percent of products consistently meet standards.”
Tyson’s Rice says AQSIQ could be the FDA’s biggest ally in protecting the U.S. consumer. Until the Dec. 11, 2007 agreement between the U.S. and China, however, U.S. government agencies did not recognize the AQSIQ and its export certificates.
“China requires all exported food must originate from AQSIQ-registered plants and be certified by the local China Inspection and Quarantine Agency (CIQ),” Rice says. “Certified food processors notify the CIQ when they are producing for export. CIQ inspectors must be present frequently during the process and must check random samples of the finished product.” Rice calls the system “rigorous.”
We are not alone
Every country and its regulatory agencies are dealing with the problems of globalization and imports. It makes sense for governments to work together to solve them. That would put a big dent in the global food safety problem.
Ultimately, the responsibility is no different than that applied within the U.S. Every food company must be responsible for the purity of its end products, and that starts with careful management of suppliers. As Rice said, Tyson relies mostly on itself to ensure its Chinese food products and ingredients are up to quality standards.
Everyone in the supply chain has a responsibility. U.S. manufacturers must demand strict standards, and foreign suppliers and their governments must meet those demands.
The experts we talked to for this article suggest U.S. companies should inspect overseas plants to verify compliance, conduct supply-chain verification, put track and trace technologies in place and continually review practices. They must keep the pressure on suppliers of imports and work hand-in-hand with FDA.
“Increasingly, Americans are buying in a global market, and we need to work at all levels to improve quality,” says Leavitt. “We need to build safety in at the front end – not inspect problems out. This means building in standards for safety at the start, where products are made.”